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Enrolling by Invitation

NCT Number: NCT07192718

Using Empowered Relief and Education To Help Postpartum Women Recover After Cesarean Delivery

The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) and educational content on global postpartum recovery at 12 weeks post cesarean delivery.

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Key information

Conditions

Cesarean Section Complications Postpartum Care

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females 18 years of age or older
  • Any woman scheduled for a cesarean delivery in the Stanford Healthcare system with a viable birth
  • English fluency
  • Ability to adhere to and complete study protocols
  • Access to smart device for zoom / video meetings

Exclusion criteria

  • <18yrs
  • chronic pain prior to pregnancy
  • Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.

Treatment and study plan

Empowered Relief

Behavioral

The participants will attend a pain relief skills intervention (Empowered Relief). The two-hour session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.

Other names: 1-Session Pain Relief Skills Intervention

Education

Other

Educational content: Participants view videos online focusing on specific areas of postpartum recovery (Sleep, Mental Health, Physical Therapy, Obstetric care).

Primary outcomes

  1. Percentage of participants registering for Empowered Relief session

    Time frame: Baseline (up to 2 weeks)

  2. Percentage of participants attending Empowered Relief session

    Time frame: Treatment (up to 2 weeks)

  3. Empowered Relief: Participant Satisfaction Scale Score

    Time frame: 1 - 2 weeks Post treatment

    Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).

  4. Empowered Relief: Participant Treatment Skills Use Scale Score

    Time frame: Week 3, Week 8, Week 14

    Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).

  5. Percentage of participants watching educational content

    Time frame: Treatment (up to 2 weeks), Week 3

  6. Educational content: Participant Satisfaction Scale Score

    Time frame: 1 - 2 weeks Post treatment, Week 3, Week 8, Week 14

    Participant satisfaction will be measured using a 7 item questionnaire with three scored items: overall usefulness (0-6), the usefulness rating of each module (0-6), and frequency of use (0-3). The composite score ranges from 0-15, with higher scores indicating greater satisfaction and use. Additional checklist and free-text items capture engagement but are not included in the score.

Secondary outcomes

  1. Change from baseline in PROMIS Pain Interference 8a scale score

    Time frame: Baseline, Week 3, Week 8, Week 14

    Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8a questionnaire, an 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. (Score range 8 - 40, higher scores represent a greater degree of pain interference).

  2. Change from baseline in PROMIS Pain Intensity 3a scale score

    Time frame: Baseline, Week 3, Week 8, Week 14

    Participants complete PROMIS Pain Intensity 3a questionnaire, a 3-item scale assessing average pain intensity for the past 7 days. (Score range 3 - 15, higher score represents a greater degree of pain intensity)

  3. Change from baseline in Pain Catastrophizing Scale Score

    Time frame: Baseline, Week 3, Week 8, Week 14

    Participants complete Pain Catastrophizing questionnaire, a 13-item scale assessing an individual's pain experience (Score range 0 - 52, higher score represents a greater degree of pain catastrophizing)

  4. Change from baseline in Pain Interference Scale Score via SMS

    Time frame: Baseline through end of study (up to 14 weeks)

    Participants complete twice weekly questionnaire to assess pain interference via SMS. (Score range 0 - 10, higher score represents a greater degree of interference)

  5. Response rate to Pain Interference scale score via SMS

    Time frame: Baseline through end of study (up to 14 weeks)

    This outcome determines the percentage of participants responding to the twice weekly pain interference scale score via SMS text.

  6. Change from baseline in PROMIS Sleep Disturbance 8a scale score

    Time frame: Baseline, Week 3, Week 8, Week 14

    Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 8a questionnaire, an 8-item scale assessing self-reported perceptions of sleep quality, sleep depth, restoration, perceived difficulties and concerns with getting to sleep/staying asleep, as well as perceptions of the adequacy and satisfaction with sleep over the past 7 days. (Score range 8 - 40, higher scores represent a greater degree of sleep disturbance).

  7. Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score

    Time frame: Baseline, Week 2, Week 3, Week 8, Week 14

    Participants complete the STORK questionnaire, a 47-item scale assessing postpartum recovery over the past 7 days. (Score range 0 - 188, higher score represents a greater degree of recovery)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

A Pilot Feasibility Trial for a Comprehensive Multimodal Intervention to Assess Global Recovery Following Cesarean Delivery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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